Consolidated Chemical recalls Humatrix Microclysmic Gel due to CGMP manufacturing violations. Products with lot numbers 3216 (exp 04/23) and 3218 (exp 10/23) may have quality issues.
CGMP Deviations: initiated due to violations of CGMP manufacturing practices
Consolidated Chemical is recalling Humatrix Microclysmic Gel bottles that were made with CGMP manufacturing violations. This could mean the product doesn't meet safety standards, but the recall doesn't specify a direct health risk or immediate action needed.
The product was made with violations of current Good Manufacturing Practices (CGMP), which are regulations designed to ensure product safety and quality. This could mean the gel might not be as safe or effective as it should be, but the recall does not specify a direct health hazard.
People who purchased Humatrix Microclysmic Gel from Care-Tech Laboratories in Saint Louis, Missouri, with lot numbers 3216 (expiring April 2023) or 3218 (expiring October 2023) are affected. Those using the product for medical purposes may be at higher risk due to potential quality issues.
Check the lot number on the bottle, which should be 3216 (expiring April 2023) or 3218 (expiring October 2023). The product is sold by Care-Tech Laboratories in Saint Louis, Missouri.
Look for lot numbers 3216 (expiring April 2023) or 3218 (expiring October 2023) on the bottle.
The recall states there were CGMP manufacturing violations, but it does not specify if the product is unsafe for use.
The recall does not provide specific action steps for consumers beyond checking the lot number.
The recall record does not mention refunds, replacements, or other remedies.
We’ve drafted a message you can send Consolidated Chemical to request your refund or repair — edit it as you like.
Subject: Recall D-0326-2023 — Consolidated Chemical Consolidated Chemical Hello, I own a Consolidated Chemical that is covered by recall D-0326-2023 from Consolidated Chemical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
